Middle School Success Over Stress

Depression Clinical Trial

— MSSOS  

Official title:

Supplement: Long-term Effects of the Family Check-up on Depression and Suicide Across Trials and Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117099
• Other study ID #: 3R01MH122213-01S1
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: January 23, 2023

Study information

• Verified date: March 2023
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is clear that the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, social/familial functioning, as well as responses to mandated safety measures (e.g. social distancing, stay-at-home orders, mask-wearing). Furthermore, families of school-age children have had to navigate online instruction and home schooling in the context of these difficult circumstances with little preparation for doing so effectively. School districts have varied widely in their ability to support parents during this crisis. These stressors are likely to have disproportionately adverse effects on lower-income and racial/ ethnic minority populations, for whom economic, academic, and family-level challenges were already pronounced. For instance, health effects of COVID-19 have hit African American and Latinx populations with disproportionate severity, including higher rates of hospitalization and death. Given the scale of pandemic impacts for families with school-aged children, the identification of effective family-focused interventions that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represent critical public health goals. In this research study the investigators will adapt and test the efficacy of the Family Check-Up Online as a treatment to foster resilient family functioning in response to the COVID-19 pandemic. The investigators will test the effects of the adapted FCU Online program on key mechanisms of change that are predicted to directly impact child and family functioning: parenting skills, parental depression, and parent and child self-regulation. The investigators predict that changes in these key targets of the intervention will impact participant's response to the COVID-19 pandemic, including youth depression and behavior problems, the ability to cope with pandemic-focused stressors, and social/familial functioning.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• A caregiver must have a child between the ages of 10 and 14;
• the caregiver must be the parent or legal guardian of the participating youth;
• the caregiver must have a smartphone with text messaging capability and access to email; and
• the caregiver must score at least 1 or above on the Patient Health Questionnaire-2, or score at least 2 on any item of the Perceived Stress Scale-4.

Exclusion Criteria:

• the caregiver is unable to read in either English or Spanish;
• the child is unable to complete the survey without parent's help; or
• the family is already participating in another study of the University of Oregon's Prevention Science Institute.

Related Conditions & MeSH terms

• Depression
• Parent-Child Relations
• Parenting
• Self-regulation

Intervention

Behavioral:
• Family Check-Up
This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be offered.

Locations

Country	Name	City	State
United States	University of Oregon Prevention Science Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Oregon	Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in parent mental health and well-being (parent report)	Parent depression will be measured with the PHQ-9.	baseline, 2 months, 4 months, 6 months
Primary	change from baseline in parental stress (parent report)	Parental stress will be measured with the Parenting Stress Index (PSI).	baseline, 2 months, 4 months, 6 months
Primary	change from baseline in child behavior and emotional problems (parent report)	Child behavior and emotional problems will be measured with the Strengths and Difficulties Questionnaire (SDQ).	baseline, 2 months, 4 months, 6 months
Primary	change from baseline in youth depression (parent report)	Youth depression will be measured with the PHQ-Parent report.	baseline, 2 months, 4 months, 6 months
Primary	change from baseline in parenting skills (parent report)	Parenting skills will be measured with the Parenting Young Children Questionnaire (PARYC).	baseline, 2 months, 4 months, 6 months
Primary	change from baseline in positive family relationships (parent report)	Positive family relationships will be measured with the CASEY.	baseline, 2 months, 4 months, 6 months
Primary	change from baseline in family conflict (parent report)	Family conflict will be measured with the CASEY.	baseline, 2 months, 4 months, 6 months
Primary	change from baseline in child self-regulation (parent report)	Child self-regulation will be measured with the Rothbart Child Behavior Questionnaire.	baseline, 2 months, 4 months, 6 months
Primary	change from baseline in youth depression (child report)	Youth depression will be measured with the PHQ-9 modified for teens.	baseline, 6 months
Primary	change from baseline in child behavior and emotional problems (child report)	Child behavior and emotional problems will be measured with the Strengths and Difficulties Questionnaire (SDQ).	baseline, 6 months
Primary	change from baseline in positive family relationships (child report)	Positive family relationships will be measured with the CASEY.	baseline, 6 months
Primary	change from baseline in family conflict (child report)	Family conflict will be measured with the CASEY.	baseline, 6 months